PMA P940015S011

Device: SYNVISC HYLAN G-F 20
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S011
Product code: MOZ
Decision date: 2008-06-09
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR THE REPLACEMENT OF THE DILUTION STATEMENT FROM THE ?PRECAUTION? SECTION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.

Current openFDA PMA Record#

Device: SYNVISC HYLAN G-F 20
Applicant: Sanofi Genzyme Corp.
PMA number: P940015
Supplement: S011
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2008-06-09
Decision code: APPR
Date received: 2007-02-20
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR THE REPLACEMENT OF THE DILUTION STATEMENT FROM THE ?PRECAUTION? SECTION AND IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NONPHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS, E.G., ACETAMINOPHEN.